Position:Jama ALM Specialist
Location:Bedford, MA (Remote)
Length:6+ months
Job Description:
Our client is currently seeking an experienced Jama ALM Specialist with a deep technical understanding of deploying Jama Connect within a medical device manufacturing environment. The ideal candidate will have hands-on experience integrating Jama into Quality Management Systems (QMS) and collaborating with cross-functional teams to ensure regulatory compliance and traceability. A key responsibility will be assisting with the migration from legacy systems like DOORS to Jama. This is an exciting opportunity to work in a dynamic, highly regulated environment.
Essential Duties and Responsibilities (but not limited to):
- Lead the deployment, configuration, and integration of Jama Connect within a QMS framework.
- Collaborate closely with cross-functional teams including Quality, Regulatory, Engineering, and IT to ensure Jama aligns with industry compliance requirements (such as ISO 13485, FDA 21 CFR Part 820, IEC 62304).
- Define and implement best practices for requirements management, traceability, and risk management using Jama ALM.
- Facilitate smooth data and workflow migration from DOORS to Jama, ensuring data integrity and system functionality.
- Provide ongoing technical support, training, and comprehensive documentation to ensure effective utilization of Jama ALM.
- Work closely with validation teams to ensure that Jama meets all regulatory and compliance standards.
- Troubleshoot, resolve, and optimize system issues, integrations, and performance.
Qualifications:
- Proven experience deploying Jama ALM within a regulated industry, ideally in medical device manufacturing.
- Strong knowledge of Quality Management Systems (QMS) and experience working with cross-functional teams in Quality, Regulatory, and Engineering.
- Demonstrated experience with requirements management, traceability, and risk analysis in regulated environments.
- Hands-on experience with migrating from DOORS to Jama is highly desirable.
- Familiarity with software validation, compliance requirements, and industry standards (ISO 13485, FDA 21 CFR Part 820, IEC 62304).
- Excellent problem-solving abilities with the capacity to train and support end-users effectively.
- Experience integrating Jama ALM with PLM, ALM, and other QMS tools is a plus.
- Knowledge of scripting and API integrations to customize Jama ALM workflows is preferred.
- Strong understanding of risk management principles and FMEA methodologies is strongly preferred.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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